Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367725
• Other study ID #: 1-10-72-122-23
• Status: Recruiting
• Start date: April 11, 2024
• Est. completion date: December 30, 2030

Study information

• Verified date: March 2024
• Source: University of Aarhus
• Contact: Birgitte K Albertsen, Professor
• Phone: +45 2022 4643
• Email: biralber[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about, the systemic exposure to dexamethason in childhood acute lymphatic leukemia (ALL). The main questions it aims to answer are:

• How does the intake of dexamethasone correlate with systemic exposure to dexamethason?

• Does systemic exposure to dexamethasone correlate with a reduction in bone mineral density?

Participants will:

• Continue to receive the best available therapy for ALL in Western Europe.

• Have blood samples taken from their central line to measure dexamethasone levels.

• When standard lumbar punctures are done as part of treatment, a sample of cerebrospinal fluid will also be taken to analyze dexamethasone.

• Visit the clinic four times for a DXA scans to measure bone density and vertebral fracture assessment: within three weeks of starting treatment, six months after starting treatment, one month after finishing treatment, and one year after finishing treatment. Biomarkers related to bone health will also be collected on these days. Additionally, participants will fill out questionnaires to track their daily physical activity levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2030
• Est. primary completion date: December 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

Inclusion Criteria:

• A diagnosis of acute lymphoblastic leukaemia

• Age 1-17.9 years

Exclusion Criteria:

• Down syndrome

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Denmark	Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital	Aalborg
Denmark	Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital	Aarhus N
Denmark	Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet	Copenhagen	København Ø
Denmark	Department of Paediatrics and Adolescent Medicine, Odense University Hospital	Odense	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity questionnaire		Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
Other	Biomarkers of bone metabolism		Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
Primary	Area Under the Plasma Concentration Curve (AUC) of Dexamethasone	Blood samples	Repeated during induction, with AUC measurements on days 3, 4, and 15. Blood samples taken before dosing, and after 1, 2, 4, and 6 hours
Secondary	Mineral bone density by DXA-scan	DXA-scan	Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
Secondary	Vertebral fracture assessment (VFA) by DXA-scan	DXA-scan	Within 3 weeks of treatment initiation, 6 months after treatment initiation, one month after ended treatment and 1 year after end of treatment.
Secondary	Dexamethasone in cerebrospinal fluid	Comparing measurements of dexamethasone in blood and cerebrospinal fluid	When lumbar punctures are performed according to standard treatment during induction